Manager/Senior Manager, Medical Writing

The Manager/Senior Manager, Medical Writing at Cogent Biosciences is responsible for leading the planning and authoring of critical clinical and regulatory documents. This includes crafting clinical study protocols and reports, collaborating with subject matter experts, performing rigorous quality control reviews, and managing contract writers. They ensure that all documents meet FDA and ICH guidelines and are scientifically accurate, maintaining consistent messaging throughout.

To qualify for the Manager/Senior Manager, Medical Writing position at Cogent Biosciences, candidates must hold a bachelor's degree. For the Manager role, a minimum of 5 years of experience in medical writing is required. The Senior Manager role calls for at least 7 years of relevant experience, or fewer years for those with advanced degrees like an MS, PhD, MD, or PharmD. Strong knowledge of regulatory processes and excellent communication skills are also essential.

Cogent Biosciences fosters a collaborative and innovative remote working environment. Medical writers in this role will interact with various departments and external contract writers, all while contributing to significant clinical projects. Employees also have access to a generous benefits package and a culture that treasures diversity and inclusion.

The Manager/Senior Manager, Medical Writing plays a crucial role in Cogent Biosciences’ mission to develop effective treatments for genetically driven diseases. By authoring and ensuring the accuracy of vital regulatory documents, the role directly supports the company’s clinical trials and the advancement of innovative therapies, ultimately contributing to enhanced patient outcomes.

Successful candidates for the Manager/Senior Manager, Medical Writing position at Cogent Biosciences need strong project and time management skills, excellent communication abilities, and a solid background in scientific writing. Proficiency in software such as Word, Excel, and Adobe suite is also necessary, along with the capability to learn new applications as required.

Yes, Cogent Biosciences is committed to the professional growth of its employees. The Manager/Senior Manager, Medical Writing will have opportunities to contribute to the development of medical writing processes, participate in clinical study teams, and potentially mentor other writers, all of which enhance skill sets and career advancement.

Compensation for the Manager/Senior Manager, Medical Writing role at Cogent Biosciences ranges from $115,360 to $183,332 annually, with a target bonus of 10-15%. The company offers a generous benefits package that includes health and dental insurance, generous time-off policies, a 401(k) plan, and additional incentives to attract top talent.

When answering this question, highlight your systematic approach to drafting clinical study protocols. Discuss how you gather input from stakeholders, ensure compliance with regulatory standards, and focus on clarity and accuracy. Sharing a specific example from your past experience can also demonstrate your expertise effectively.

Illustrate your willingness to accept constructive feedback by emphasizing how you view it as an opportunity for improvement. Explain your process for incorporating feedback while maintaining the integrity of the document, prioritizing collaboration and communication with your team.

Discuss your experience facilitating document reviews, emphasizing your ability to lead discussions with stakeholders. Share specific strategies you’ve used to ensure that meetings are productive and that consensus is achieved efficiently.

Talk about your familiarity with FDA and ICH guidelines and how you stay updated on changes in regulatory requirements. Explain your process for ensuring compliance, such as creating checklists or consulting with regulatory experts during the drafting process.

Provide a specific example that showcases your skills in simplifying complex information. Describe your target audience, the challenges you faced, and the techniques you employed to ensure clear and effective communication.

Describe your project management techniques, such as prioritizing tasks, using project management tools, and adhering to deadlines. Illustrate how you maintain organization and ensure high-quality output when juggling multiple projects.

Emphasize your teamwork skills by explaining how you work closely with scientists, project managers, and regulatory teams. Discuss your methods for fostering effective communication and how you gather insights from various stakeholders to enhance your writing.

List specific tools you are experienced with, such as Microsoft Word, Excel, Veeva RIM, and Adobe Suite. Discuss how you leverage these tools to enhance the efficiency and quality of your writing, and express your versatility in learning new software as required.

Detail your quality control processes, emphasizing attention to detail and thoroughness. Discuss how you review documents for clarity, accuracy, and compliance before submitting them and your techniques for incorporating peer reviews.

Articulate your passion for biotechnology and specifically why Cogent Biosciences' mission resonates with you. Discuss how your skills and experience align with the role and how you envision contributing to the company's goals in precision drug development.